BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3895713 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-22032
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    January 8, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    NOTIFICATION THAT LITIGATION HAS BEEN FILED RECEIVED FROM LEGAL DEPARTMENT ON (B)(4) 2014. SPREADSHEET SHOWS LEGAL DEPARTMENT RECEIVED THIS INFORMATION ON (B)(4) 2014, AS PART OF THE SETTLEMENT REGISTRATION PROGRAM.

    Description of Event or Problem · 1

    UPDATE REC'D 01/08/2015- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. THE DOI WAS UPDATED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE COMPLAINT WAS UPDATED ON: 01/20/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372118 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other